How MS Patients Lost Their Patience, Got Mouthy, and the FDA Listened

In the old days of multiple sclerosis care — say, circa 1990 — the medical research community and a passive MS patient population were united in their hopes that they would soon see either an improved therapy or an out-and-out cure. Obviously such breakthroughs would serve the individual needs of scientists and patients alike. Success in the lab would mean more future dollars spent there, and success for MS patients would mean better quality of life. But things have changed since the early days of interferon therapies. For one, patients have gotten mouthier, more educated, more demanding — and downright ungrateful. All power to us for taking that big step forward in attitude. More on that later.

We grew desperate

So why the attitude change? We grew up. Or grew desperate. Maybe desperation makes us grow up. Since necessity is the mother of invention, it became doggone necessary for us to push for more, better, and faster ones. It shouldn’t have been that perplexing to health care providers, but it was at first, in much the same way parents are initially startled and not a little dismayed when their children display an independent streak. Independence means more than taking responsibility for one’s compliance with a treatment program and showing up on time for numerous appointments. It means stepping back and observing the broader spectrum of treatment possibilities with an open mind and a pioneer spirit. It means taking on more risk.

The risk of PML

For example, the risk of trying a newly-approved therapy with a troubled track record such as Tysabri in 2006—after it initially was approved in 2004 but then withdrawn from the market in the wake of 3 PML cases and 2 deaths that occurred among three of the original 3,000 trial subjects. Biogen re-released it with a black box warning that helps patients and their doctors make a more informed choice. Those PML cases had a history of immunosuppressant therapy prior to the trial, weakening their immune systems and rendered them JCV-positive. We pushed on despite the risks.

Experimental stem cell treatments

More recently, our pioneering spirit aims at taking part in experimental stem cell treatments performed outside the country. This year stem cell research is either ramping up for or engaged in early trials in some New York venues. So many people are watching for the outcomes. Some are literally dying to try it. On their private clock, time is fast running out. We all sense that things have sped up, but it still feels like hurry-up-and-wait. Is it possible that our new spirit of manifest destiny persuaded the FDA to ease up on its strict approval process and float us a break?

Drugs with marginal benefits

According to Forbes writer Matthew Herper, it has. In his 2015 article: The FDA Is Basically Approving Everything and Here’s The Data To Prove It, he states “... the FDA has had a program to ask patient advocates what they want. Many sick patients would prefer that the FDA approve a drug with a marginal benefit than reject it.” So there it is, an unequivocal fact that once we MS patients demanded participation in the approval process, they rolled out the red carpet. Sure, the drug companies stand to make a bundle, but that’s another story. There is a pretty direct, personal potential benefit to having access to a drug with marginal impact.

Moderate success with Ampyra

For example, I take Ampyra for my legs. Trials showed it helped 40 percent of subjects walk faster compared to placebo. Though I'm one of the lucky ones it helps, many people try it and experience no benefit. Depending on how you choose to look at it, 40 percent seems a low percentage compared to other symptom medications, but rates average-to-high compared to some of our disease-modifying therapies.

Your voice matters

So if you think it isn’t worth it to tell your patient support program reps how to improve your experience, or participate in patient-centered surveys and data projects that will shape and inform MS patient care, then look at your pill organizer and syringes and think about how your life might be if those drugs weren’t available. And if you’re feeling sheepish about a frustrated outburst at your last medical appointment/procedure, please forgive yourself.

If you don’t spew, they’ll say they never knew. Get mouthy. The life you save might be your own.

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This article represents the opinions, thoughts, and experiences of the author; none of this content has been paid for by any advertiser. The team does not recommend or endorse any products or treatments discussed herein. Learn more about how we maintain editorial integrity here.

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